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VAD044 Part I

Phase 1

Hereditary Hemorrhagic Telangiectasia (HHT) | Small molecule | Other |cbdMD, Inc.|Last Updated: Mar 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

VAD044 Part I · 1 trial · 1 indication

Phase 1 1
NCT05406362Assess Safety and Efficacy of VAD044 in HHT PatientsHereditary Hemorrhagic Telangiectasia (HHT)
ACTIVE NOT_RECRUITING75 Analytics
PHASE1ACTIVE NOT_RECRUITING
Assess Safety and Efficacy of VAD044 in HHT Patients
Hereditary Hemorrhagic Telangiectasia (HHT)Unlock trial analytics

Study Endpoints

Primary Endpoints

Part I: Safety and Tolerability
12 weeks

Type and severity of Adverse Events (AEs)

Part II: Safety and Tolerability
36 months

Type and severity of Adverse Events (AEs)

Secondary Endpoints

Part I: Change in Epistaxis episodes
12 weeks
Part I: Change in Epistaxis duration
12 weeks
Part I: Change in Epistaxis intensity
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
30 mgEXPERIMENTAL30 mg VAD044
40 mgEXPERIMENTAL40 mg VAD044
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
VAD044 Part IDRUGcapsules to be taken once daily for 12 weeks
VAD044 Part IIDRUGcapsules to be taken once daily for 36 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

For Part I of the study: Inclusion Criteria: * Diagnosis of HHT by the Curaçao criteria * Several epistaxis/week * Anaemia * COVID-19 vaccination or positive COVID-19 antibody test * Patient has given written informed consent to participate in Part I Exclusion Criteria: * Type 1 diabetes or unco...

Countries:United StatesBelgiumFranceItalyNetherlandsSpain
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Frequently asked questions about VAD044 Part I

What is VAD044 used for in Hereditary Hemorrhagic Telangiectasia (HHT)?

VAD044 is an investigational small molecule being studied for the treatment of Hereditary Hemorrhagic Telangiectasia (HHT), a genetic disorder characterized by abnormal blood vessel formation. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes VAD044?

VAD044 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Hereditary Hemorrhagic Telangiectasia (HHT).

What phase is VAD044 in?

VAD044 is currently in Phase 1 clinical development. It is an investigational drug being studied for Hereditary Hemorrhagic Telangiectasia (HHT) and has not yet received regulatory approval. The ongoing Phase 1 trial is active but not recruiting participants.

What clinical trials is VAD044 in?

VAD044 is being evaluated in a Phase 1 clinical trial with the identifier NCT05406362, titled 'Assess Safety and Efficacy of VAD044 in HHT Patients.' This randomized, double-blind, placebo-controlled trial is enrolling 75 participants aged 18 years and older with Hereditary Hemorrhagic Telangiectasia (HHT) across the United States, Belgium, France, Italy, Netherlands, and Spain.

Is VAD044 FDA approved?

No, VAD044 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for Hereditary Hemorrhagic Telangiectasia (HHT). The drug is being studied for safety and efficacy but has not yet completed the clinical development process required for regulatory approval.